Sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]

Accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new OPTN liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]

Diagnostic value of sensitivity and PPV when patients are stratified by AFP level (elevated vs normal) [ Time Frame: Within 90 Days Before Transplantation ] [ Designated as safety issue: No ]

Participants undergo CT and MRI every 90 days for the trial, during liver transplant wait listing. The primary objective is to assess the two modalities as radiologists apply the updated liver transplantation policy, which integrates the same imaging parameters as are being measured in ACRIN 6690. This trial will define how well the policy is functioning to improve stewardship in liver allocation.

A sub-study introduces the Eovist contrast agent for MRI scans at the same time points as the parent policy-assessment trial.

Detailed Description:

OBJECTIVES:

Primary

To compare the sensitivity of multiphase contrast-enhanced CT scan to that of multiphase contrast-enhanced MRI using non-specific contrast agents for diagnosing hepatocellular carcinoma (HCC) in patients with chronic liver disease.

Secondary

To compare the positive predictive value (PPV) of CT scan to that of MRI for diagnosing HCC.

To compare the lesion-level sensitivity and PPV of CT scan and MRI as interpreted by radiologists at the respective transplant centers.

To compare the sensitivity and specificity of multiphase contrast-enhanced CT scan vs MRI for diagnosing residual or recurrent HCC after local ablative therapy in patients listed for liver transplant.

To determine the accuracy of imaging-based diagnosis and staging of HCC in clinical practice using the new Organ Procurement and Transplantation Network (OPTN) liver-imaging criteria compared with the reference standard of pathologic diagnosis and staging at the time of explantation.

To explore whether the comparisons of sensitivity and PPV are affected by stratifying patients by AFP level (elevated vs normal). (Exploratory)

Tertiary

To assess the sensitivity and PPV of MRI and CT interpreted at the participating sites on the basis of all available information and sequences and compare the sensitivity and PPV of the two modalities interpreted using the main study criterion. (Exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to AFP level (elevated vs normal).

Patients undergo CT scan with iodinated contrast agent and MRI with extracellular gadolinium contrast agent (both standard-of-care and study-related) at baseline and at 90-day intervals while on the liver transplant wait list.

After transplantation, the explanted liver will be analyzed for biomarkers and other studies.

None of the following conditions that would make the patient unsuitable to undergo CT scan with an iodinated contrast agent:

Iodinated contrast allergy

Weight greater than that allowable by the CT table

No known allergy-like reaction to contrast media (iodinated or extracellular gadolinium that does not have dominant hepatobiliary excretion) or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology and unwilling to undergo pre-treatment

Patients planning to undergo local ablative therapy after transplant listing and study enrollment are eligible provided they undergo CT scan and MRI within 28-60 days after completing the last ablative therapy session

Patients planning to receive transcatheter arterial chemoembolization (TACE) or combination therapy with TACE and thermal ablation are eligible provided they complete the entire treatment scheme per institutional standard of care before undergoing CT scan and MRI

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01082224